Regulatory Data Packages
From Regulatory Data Generation to Global Submission
Navigate complex regulatory milestones with integrated scientific, documentation, and submission support throughout the drug development lifecycle. WuXi Biology and Testing combines nonclinical and clinical testing, regulatory strategy, dossier preparation, SEND-compliant datasets, eCTD publishing, and health authority communication to help sponsors prepare regulatory submissions for clinical development and marketing authorization across global markets.
This approach supports regulatory requirements for agencies worldwide, including U.S. regulatory agencies, European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), China's National Medical Products Administration (NMPA), and other global health authorities.
IND-Enabling Packages Supported
On-Time Data Report Delivery
NDA-Enabling Packages Supported
From Regulatory Data Generation to Global Submission
A successful regulatory submission requires more than a collection of individual study reports. Sponsors must coordinate high-quality data across nonclinical, clinical, and Chemistry, Manufacturing and Controls (CMC) disciplines; identify and address dossier gaps; prepare compliant documentation; and communicate effectively with health authorities worldwide. WuXi Biology and Testing provides integrated regulatory affairs and laboratory testing support for regulatory submissions, including clinical trial applications, marketing authorization applications, and other regional regulatory filings submitted to global health authorities.
WuXi Biology and Testing provides integrated regulatory affairs and laboratory testing support for IND and NDA applications submitted to global health authorities, including U.S. regulatory agencies, China’s National Medical Products Administration, and the European Medicines Agency. Our regulatory professionals can support submission strategy, document preparation, dossier composition, eCTD submission, agency meetings, and post-submission activities.
By coordinating regulatory affairs with CMC, nonclinical, and clinical teams, we help sponsors reduce administrative complexity, identify potential issues earlier, and maintain momentum from preclinical development through marketing application.
Regulatory Support Across the Drug Development Lifecycle
Regulatory requirements evolve as a candidate moves from preclinical development into clinical trials and toward commercialization. WuXi Biology and Testing supports sponsors at each major milestone with coordinated testing, reporting, and regulatory affairs services.
For U.S. regulatory submissions, an IND application focuses on demonstrating that a candidate is sufficiently characterized and supported by appropriate nonclinical safety, pharmacology, DMPK, CMC, and clinical planning information to begin human trials. Similar requirements apply to clinical trial applications submitted in other regions.
For marketing applications, such as a U.S. NDA or a Marketing Authorisation Application (MAA) in Europe, sponsors must provide comprehensive evidence supporting the product's quality, safety, efficacy, and benefit-risk profile.
Our Regulatory Data Package Capabilities
IND Package Preparation and Submission
WuXi Biology and Testing supports the preparation of IND applications by coordinating the scientific data, reports, summaries, and regulatory documents needed to begin clinical development.
Capabilities may include:
- Regulatory strategy and submission planning
- Gap analysis and feasibility assessment
- Nonclinical pharmacology and toxicology reports
- DMPK and toxicokinetic documentation
- Bioanalytical method and sample analysis reports
- CMC documentation and authoring support
- Initial clinical protocol support
- CTD dossier preparation
- eCTD publishing and submission
Our integrated teams help align program activities with submission requirements while maintaining consistency across the application.
NDA Package Preparation and Submission
WuXi Biology and Testing supports NDA-enabling development and application preparation from clinical development through marketing submission.
NDA support may include:
- NDA regulatory strategy and planning
- Dossier gap analysis
- Long-term general toxicology studies
- Developmental and reproductive toxicology
- Carcinogenicity assessments
- Juvenile toxicology, when applicable
- Clinical bioanalytical testing
- Clinical pharmacokinetic sample analysis
- Human mass balance and metabolite studies
- Biomarker analysis
- CMC authoring and lifecycle support
- CTD dossier composition
- eCTD submission
Our NDA-enabling services are designed to coordinate the complex reporting and testing needs that emerge as programs advance through Phase I, Phase II, and Phase III studies.
CTD and eCTD Dossier Preparation
WuXi Biology and Testing’s regulatory team can support the preparation and coordination of the electronic Common Technical Document modules required for submission.
SEND Dataset Services
The Standard for Exchange of Nonclinical Data provides a consistent electronic structure for submitting applicable nonclinical study data to the U.S. regulatory agencies.
WuXi Biology and Testing ’s SEND services include:
- Instem’s Submit v5.1.2
- DefineNow v2.3.0
- Provantis® Software
We are well versed in importing data from clients and outsourced partners to develop validated SEND data packages.
We use the latest technologies for data collection, management and presentation, ensuring that data packages are compliant with U.S. regulatory agency SEND requirements, as well as 21 CFR Part 11.
Data can be accessed via our Provantis® Portal™ within 24 hours of acquisition, and we provide SEND data sets within 10 business days of the report date.
Integrated Program Management
Regulatory submissions depend on coordinated work across CMC, nonclinical, clinical, bioanalytical, and regulatory functions. WuXi Biology and Testing provides dedicated program management to help sponsors maintain visibility and alignment throughout the process.
Program management support can include:
- A dedicated point of contact
- Integrated timelines and milestone tracking
- Cross-functional team coordination
- Study and documentation planning
- Progress updates and teleconferences
- Risk identification and issue resolution
- Dossier preparation coordination
- Submission readiness tracking
Regulatory Agency Communication
Effective communication with health authorities can help clarify expectations, resolve questions, and reduce uncertainty during development and review.
WuXi Biology and Testing can support:
- Pre-IND and other regulatory meetings
- Meeting requests and briefing packages
- Meeting organization
- Submission-related correspondence
- Inspection coordination
- Global regulatory liaison activities
The regulatory team supports communication with agencies including U.S. regulatory agencies, NMPA, EMA, OECD, MHRA and other regulatory authorities.
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Frequently Asked Questions
A regulatory data package is the collection of scientific data, study reports, summaries, datasets, and supporting documentation used in a regulatory application. Depending on the development stage, it may support an IND, NDA, or another global submission.
An IND package typically includes administrative information, CMC documentation, nonclinical pharmacology and toxicology data, previous human experience when applicable, and the proposed clinical protocol and investigator information.
An NDA package typically includes comprehensive CMC, nonclinical, and clinical evidence supporting the product’s quality, safety, efficacy, and benefit-risk profile. It may also include labeling, administrative documents, integrated summaries, and supporting electronic datasets.
IND-enabling development generates the evidence needed to support initial human clinical trials. NDA-enabling development expands the evidence base through longer-term nonclinical studies, clinical trials, CMC development, clinical bioanalysis, and other activities required to support marketing approval.
SEND datasets organize applicable nonclinical study data according to CDISC standards for electronic submission. They help regulatory reviewers efficiently navigate and analyze standardized study data.
Yes. WuXi Biology and Testing supports IND and NDA development, documentation, and submission activities, including filings to health authorities such as U.S. regulatory agencies, NMPA, and EMA.
Post-IND support may include annual reports, Development Safety Update Reports, regulatory amendments, supplemental applications, expedited pathway support, health authority communication, and other lifecycle regulatory activities.